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Quotable: Top Experts On Policy Hot Topics

 
• By Neena Brizmohun

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

• Source: Shutterstock

“We want an agreement, and we clearly state that companies are willing to commit to binding mandatory obligations to share, whether it's with the WHO, GAVI UNICEF or UNITAID, for rollout to those with the highest medical needs, provided the system is workable.” – International Federation of Pharmaceutical Manufacturers and Associations’ outgoing director general Thomas Cueni on the WHO pandemic treaty. Find out more: 'Don’t Compromise The Pharma Innovation System,' Says Outgoing IFPMA Head Thomas-Cueni

“It is hugely encouraging to see pioneering funding solutions being developed and realized across Europe.” – CSL’s Lutz Bonacker on Austria’s new dedicated supra-national fund for high-priced and specialized medicines

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More from International

Quotable: Top Experts On Policy Hot Topics

 
• By Anabel Costa-Ferreira

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Companies Advised To Assess Potential Impacts Of Landmark Global Pandemic Treaty

 
• By Neena Brizmohun

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.

ICH Modernizes Stability Testing Guideline

 
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The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

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US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
• By Sue Sutter and Derrick Gingery

Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.

Brazil’s Drug Pricing Shake Up Calls For More Robust Evidence From Companies

 
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EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
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The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.